Company
United StatesImpladent Ltd., Jamaica, NY – FDA Inspections
Inspection records and compliance data for Impladent Ltd. in Jamaica, New York. 8 FDA inspections on record (1 OAI), 1 warning letter, last inspected February 19, 2025.
Company Profile
This profile covers Impladent Ltd. based in Jamaica, New York, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 1
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected October 29, 2009. Last inspected February 19, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 19, 2025 | Not classified | Biologics | 1261471 |
| October 11, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1068877 |
| November 12, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 953515 |
| November 5, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 947769 |
| November 12, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 855776 |
| September 26, 2013 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 850573 |
| November 3, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 753615 |
| October 29, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 625455 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Impladent Ltd.
FEI Number
2431866
Address
8690 188th St, Jamaica, New York 11423, United States
Country
United States
ID: d8713d2d-2746-4f0a-b416-706524f61a7a